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EC number: 200-915-7 | CAS number: 75-91-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, adequate for evaluation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Staatstoezicht op de Volkgezondheid, 22 March 1993
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- tert-butyl hydroperoxide
- EC Number:
- 200-915-7
- EC Name:
- tert-butyl hydroperoxide
- Cas Number:
- 75-91-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 2-methylpropane-2-peroxol
- Details on test material:
- - Aqueous solution containing ca. 70wt% TBHP
- Clear, colourless aqueous liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female young adult Swiss mice (Charles River CD-1 strain) were obtained from Charles River Wiga GmbH, Sulzfekld, Germany and housed in Makrolon cages with bedding of sterilized softwood chips. Males were housed individually and weight 28-35 g at the start of treatment, females were group housed (5 / cage) and weighed 22-28 g at the start of treatment. Fresh pelleted diet (TNO Rodent G diet) and tap water were available ad libitum.
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- saline
- Details on exposure:
- The i.v. route (tail vein) was selected in order to maximise the bioavailability of the test substance.
- Duration of treatment / exposure:
- 24, 48 and 72 hr
- Frequency of treatment:
- single i.v. treatment
- Post exposure period:
- 24, 48 and 72 hr
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bwt
Basis:
nominal conc.
Dose levels selected on the basis of 2 preliminary i.v. range finding toxicity trials
- Remarks:
- Doses / Concentrations:
70 mg/kg bwt
Basis:
other: actual dose
- No. of animals per sex per dose:
- Test groups: 15 male, 15 female
Positive controls: 5 male - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- A concurrent positive control group (5 males) was given mitomycin C (1.5 mg/kg bwt) by i.p. injection and sacrificed 24 hours post-treatment.
Examinations
- Tissues and cell types examined:
- All animals were observed for clinical signs 1-4 hr post-treatment.
- Details of tissue and slide preparation:
- Animals (5/sex) were sacrificed by cervical dislocation at 24, 48 and 72 hr post-injection. Femoral bone marrow was immediately collected into foetal calf serum, and 2 air-dried, methanol fixed smears were prepared per animal and stained with May-Grunwald Giemsa.
- Evaluation criteria:
- The slides were randomly coded and scored blind for:
- the number of polychromatic (PE) and normochromatic erythrocytes (NE) present in a total of 1000 erythrocytes (E) per animal.
- the number of micronucleated polychromatic erythrocytes (MPE) or micronucleated normochromatic erythrocytes (MNE) per 1000 erythrocytes - Statistics:
- The number of incidence of MPE per 1000 PE and the number of PE per 1000 E from the vehicle control and test groups was analysed using 3-way ANOVA with sex (male, female), group (control, test) and time (24 hr, 48 hr, 72 hr) used as factors.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- (consistent with TK data indicating negligible systemic distribution)
- Toxicity:
- yes
- Remarks:
- seen in rangefinder at 200 mg/kg bwt
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The incidence of micronucleated polychromatic erythrocytes (MPE) per 1000 polychromatic erythrocytes (PE) did not differ significantly from that of the vehicle controls at any sacrifice time indicating no genotoxic effect on bone marrow cells. The incidence of MPE in the positive control group was increased approx. 22-fold.
The incidence of polychromatic erythrocytes (PE) per 1000 erythrocytes in male mice (PE) did not differ significantly from that of the vehicle controls at any sacrifice time indicating no cytotoxic effect of TBHP on bone marrow. In female mice at 48 hr and 72 hr the number of PE per 1000 E was increased slightly (+24% at 48 hr, +36% at 72 hr; P0.05) suggesting a weak interaction with bone marrow.
These findings are consistent with toxicokinetic data that indicate that TBHP is rapidly converted to tert-butanol in vivo, limited any potential for systemic genotoxic effects.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
TBHP was not genotoxic in the mouse micronucleus test after i.v. injection. - Executive summary:
The clastogenic potential of TBHP toward bone marrow cells was investigated in male and female mice following i.v. injection (nominal dose 100 mg /kg bwt; actual dose 70 mg TBHP /kg bwt). Femoral bone marrow was collected 24, 48 and 72 hr post-injection, and preparations examined blind for the presence of normal or micronucleated polychromatic and normochromatic erythrocytes. The study was GLP-compliant and followed EU Method B.12 (guideline study). The incidence of micronucleated polychromatic erythrocytes per 1000 polychromatic erythrocytes did not differ significantly from that of the vehicle controls at any timepoint indicating no genotoxic effect on bone marrow cells. The incidence of micronucleated polychromatic erythrocytes in a positive control group (cyclophosphamide) was increased approx. 22-fold. There was no change in the incidence of polychromatic erythrocytes in TBHP-treated male mice at any sacrifice time suggesting no exposure to TBHP; in female mice, the number of PE was increased slightly at 48 hr and 72 hr suggesting a weak interaction. These findings are consistent with ADME data which demonstrate negligible systemic distribution of TBHP due to its rapid conversion to 2-methylpropan-2-ol (tert-butanol).
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